Engaging Informal Health Care Providers on Case Detection and Treatment Initiation Rates for TB and HIV in Rural Malawi (Triage Plus) (Triage)
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| ClinicalTrials.gov Identifier: NCT02127983 |
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Recruitment Status :
Completed
First Posted : May 1, 2014
Last Update Posted : May 1, 2014
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Sponsor:
Liverpool School of Tropical Medicine
Collaborators:
Research for Equity And Community Health REACH Trust
Ministry of Health and Population, Malawi
LHL International Tuberculosis Foundation
University of Warwick
Information provided by (Responsible Party):
Liverpool School of Tropical Medicine
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Brief Summary:
The intervention consisted of training non-paid informal healthcare providers (such as store-keepers) in TB and HIV disease recognition, sputum specimen collection, referral to the public health system, and raising community awareness. Front line public health personnel and community leaders were sensitised to support the intervention.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Tuberculosis HIV | Behavioral: Early intervention Behavioral: Delayed intervention | Not Applicable |
A phased, matched, parallel cluster design was used to randomise three clusters (average population size per cluster = 200,714) to the Early intervention arm (received the intervention early in the first 12 months) and an equal number to the Delayed intervention arm (average population size per cluster = 209,564) which received the intervention after one year. Data for impact evaluation were obtained from routine patient registers in all the health facilities and patients were blindly allocated to the respective clusters based on residential address. Treatment initiation rates (expressed as incidence rate ratios) for TB and Anti Retroviral Therapy (ART) over the 12 months period were the primary outcome measures for each of the studied conditions. Poisson regression models with robust standard errors were used to assess the effectiveness of the intervention.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 200000 participants |
| Allocation: | Randomized |
| Intervention Model: | Crossover Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Health Services Research |
| Official Title: | Engaging Informal Health Care Providers on Case Detection and Treatment Initiation Rates for TB and HIV in Rural Malawi (Triage Plus): a Cluster Randomised Health System Intervention Trial |
| Study Start Date : | January 2009 |
| Actual Primary Completion Date : | December 2011 |
| Actual Study Completion Date : | December 2012 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Early intervention
Early intervention arm engaging informal providers Received the intervention early in the first 12 months
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Behavioral: Early intervention
Training non-paid informal healthcare providers (such as store-keepers) in TB and HIV disease recognition, sputum specimen collection, referral to the public health system, and raising community awareness. Front line public health personnel and community leaders were sensitised to support the intervention Other Names:
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Active Comparator: Delayed intervention
Delayed intervention arm, engaging informal providers Received the intervention after one year
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Behavioral: Delayed intervention
Delayed intervention arm, engaging informal providers Received the intervention after one year |
Primary Outcome Measures :
- TB and HIV treatment initiation [ Time Frame: 2 years ]the cumulative counts of patients initiating TB and HIV treatment per 10,000 adults aged 12 years and above each month over the intervention period
Secondary Outcome Measures :
- TB and HIV diagnostic uptake rates. [ Time Frame: 2 years ]
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| Ages Eligible for Study: | 16 Years and older (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- People accessing informal providers with possible TB or HIV
Exclusion Criteria:
- children
- people already with a diagnosis of TB or HIV
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02127983
Locations
| Malawi | |
| REACH Trust | |
| Lilongwe, Malawi | |
Sponsors and Collaborators
Liverpool School of Tropical Medicine
Research for Equity And Community Health REACH Trust
Ministry of Health and Population, Malawi
LHL International Tuberculosis Foundation
University of Warwick
Investigators
| Principal Investigator: | Rachael Thomson, MSc | LSTM |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Liverpool School of Tropical Medicine |
| ClinicalTrials.gov Identifier: | NCT02127983 History of Changes |
| Other Study ID Numbers: |
TriagePlus |
| First Posted: | May 1, 2014 Key Record Dates |
| Last Update Posted: | May 1, 2014 |
| Last Verified: | December 2012 |
Keywords provided by Liverpool School of Tropical Medicine:
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TB, HIV, case finding, access, informal providers |
Additional relevant MeSH terms:
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Tuberculosis Mycobacterium Infections Actinomycetales Infections Gram-Positive Bacterial Infections Bacterial Infections |